Cleared Traditional

K813565 - RADIATION STERILIZED SURGEON'S GLOVES

K813565 is the FDA 510(k) clearance for RADIATION STERILIZED SURGEON'S GLOVES by Travenol Laboratories, S.A.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K813565 · Travenol Laboratories, S.A. · General Hospital
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Jan 1982
Decision
31d
Days
Class 1
Risk

K813565 is an FDA 510(k) clearance for the RADIATION STERILIZED SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K813565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1981
Decision Date January 22, 1982
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K813565.
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984
VANISH II
K833093 · Warner-Lambert Co. · Dec 1983
DESERET SURGEON'S GLOVE ACCESSORY
K823086 · Parke-Davis Co. · Jan 1983
DESERET NEOLON SURGICAL GLOVES
K813088 · Warner-Lambert Co. · Dec 1981
SURGEON'S GLOVES
K811753 · Travenol Laboratories, S.A. · Sep 1981
SURGIKOS NEUTRALON BR. SURGEON'S GLOVE
K800152 · Surgikos, Inc. · Feb 1980